Cortical Reorganisation in Patients With Primary Headache... | NCT00263991

Studies
Cortical Reorganisation in Patients With Primary Headache Disorders

NCT00263991

Sponsor

Danish Headache Center

Status

Unknown status

Last Update Posted

Dec 12, 2005Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Migraine Without Aura
Chronic Tension-Type Headache

Interventions

EEC-techniques

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 9, 2005

First Submission Date that Met QC Criteria

Dec 9, 2005

First Posted Date

Dec 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2005

Last Update Posted Date

Dec 12, 2005Estimated

Description Module

Brief Summary

Primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to clarified and the existing neurophysiological methods have not yet been useful. More sensitive and reliable methods are therefore highly needed. The aims of the study are therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation and expansion of pain sensitive cortical areas in patients with migraine or tension-type headache.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
EEC-techniques	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis og migraine without aura or chronic tension-type headache

Exclusion Criteria:

serious somatic or psychiatric diseases including depression
overuse of analgesics
regular intake of opiates or benzodiazepines
intake of prophylactic headache medication
pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Bendtsen, MD, Ph.d	Danish Headache Center, Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center; Department of Neurology, Glostrup Hospital, University of Copenhagen		Glostrup, Copenhagen		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020326	Migraine without Aura

Ancestor Terms

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

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Browse Branches

Not provided